Evaluation of Effect of Excipients on Atropine Sulphate by UV Spectroscopy

Atropine sulphate is a widely used anticholinergic drug, particularly in ophthalmic formulations and its analytical evaluation is essential to ensure quality, stability and safety. The present study was undertaken to evaluate the effect of selected excipients on the UV spectroscopic characteristics of atropine sulphate using a Quality by Design (QbD) approach. UV-Visible spectrophotometry was employed as a simple and economical analytical technique. The UV absorption spectrum of atropine sulphate was recorded in the wavelength range of 200-400nm, and the drug exhibited a maximum absorbance (λmax) at 257nm, which was selected for further analysis. The influence of excipients such as sodium chloride (NaCl), sodium citrate (Na3C6H5O7) and sodium hydroxide (NaOH) on the UV behavior and stability of atropine sulphate was studied. Forced degradation studies under thermal stress, pH variation, and concentration changes were carried out to assess degradation behavior. A QbD-based design of experiments (DoE) approach using Box-Behnken design was applied to evaluate the effect of critical process parameters such as concentration, temperature and pH on percentage recovery. Statistical analysis using ANOVA conformed the significance of the developed models. The results demonstrated that excipient type and experimental conditions significantly influence the UV spectroscopic response and stability of atropine sulphate. The study concludes that the developed UV spectrophotometric method is robust, reproducible, and suitable for analytical and formulation studies of atropine sulphate.